Supreme Court Rules in Favor of Accelerated Process for Biosimilars

In a unanimous ruling, the U.S. Supreme Court overturned a lower court’s decision that stipulated manufacturers of biosimilar products must wait 6 months after the reference product’s exclusivity expires before selling biosimilar versions.

In the suit, Amgen Inc., the manufacturer of Neupogen (filgrastim), sued Sandoz Inc., after the latter began selling Zarxio, a biosimilar version of Neupogen, which received approval in 2015 from the U.S. Food and Drug Administration (FDA) once the reference drug lost exclusivity. Sandoz successfully argued that a lower court’s interpretation of the Biologics Price Competition and Innovation Act of 2009 unfairly granted Amgen 6 months of exclusivity in addition to the 12 years already provided under law.

Writing for the court, Justice Clarence Thomas said that the decision was not based on policy arguments, but rather the “plain language” of the biosimilar law itself, which states that the biosimilar applicant must notify the biologic sponsor within 180 days before commercial marketing – allowing the applicant to provide notice even before the FDA approves this marketing.

It also ruled that the reference product manufacturer cannot force a biosimilar applicant to disclose application and manufacturing information through an injunction.

Manufacturers of the reference product can, however, seek remedy for patent infringement. Biosimilars are typically less expensive than their reference products, so these rulings could translate to billions of dollars in lost revenue for the biologic sponsors.

Sources: Reuters, June 12, 2017; JD Supra, June 16, 2017.